2025 India CDISC Day Call for Abstracts

Instructions

Please use the form below to submit your abstract for consideration. PLEASE MAKE SURE TO PRESS THE SUBMIT BUTTON AT THE BOTTOM OF THE FORM. You should see a confirmation page after successful submission.

2025 India CDISC Day Call for Abstracts 

Abstracts Due: Friday, 25 October 2024

We welcome abstracts for the 2025 India CDISC Day on any of the CDISC topics listed below.

Open Source usage, including CORE, OAK, ARS, COSMoS

  • Experience in the use of CORE, Rules Authoring Tool and generation of Rules
  • Experience of various validation tools for SEND/SDTM/ADaM/Define
  • Experience in use of Open Source tools
  • Implementation examples of ARS

CDISC Foundational Standards

  • CDASHIG 2.3/3.0
    • Sexual Orientation & Gender Identity (SOGI)
  • SDTM/IG 2.2/4.0
    • Preparing for SUPP to NSV Transition
  • ADAM 3.0/1.4
  • SEND/IG 2.2/4.0
  • Define-XML v2.1
    • upversioning from 2.0 experience
  • CT domain changes

Regulatory Submissions

We invite you to share how you are handling changes in submission requirements, versions of standards, and country-specific requirements, and new FDA guidance documents (such as the Standard Safety Tables and Figures). What lessons can you share from these experiences?

  • Submission to FDA/PMDA/NMPA learnings
  • Submitting around the Globe, submission experience with other Health Authorities e.g. EMA Clinical Trials Raw Data Pilot
  • Supporting FDA BIMO Deliverables
  • Achieving quality and efficiency in data submission e.g.
    • Proper documentation
    • How to correctly provide metadata in define-xml
    • Automation
    • Process flow
  • Impact of new FDA guidance e.g.
    • Standard Safety Tables and Figures Guide
    • Experience and adherence to FDA division guidance e.g., CBER Vaccine, CDER NASH, etc.
    • Inclusion and diversity requirements and challenges from standards point of view e. g. Gender How to correctly provide metadata in define-xml
    • RWE impacts decision making by regulators – opportunities and challenges from data standards/harmonization/review
  • Experience integrating data from multiple studies in support of Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE)
  • Imagine Data Submission in 2041: how technology, standards and industry initiative can fasten data submission
Contact Information
Please include your mobile phone number where you can be reached, in case we're unable to contact you by email. 
Abstract Submission
General Topic

Upload paper (not required).

After uploading, you MUST also hit the "Submit" button at the bottom of the form to submit your abstract.

One file only.
30 MB limit.
Allowed types: pdf, doc, docx.
  1. All author(s) approve submitting this work for presentation.
  2. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation.
  3. The presenting author will be available to present the abstract in person in Bengaluru, India if selected for the program. The presenting author will immediately notify CDISC if they are unable to present an abstract or if the presenting author changes.
  4. Submission of the contact details provided are those of the presenter of the abstract. The primary author will be notified about the status of the abstract and is responsible for informing the other authors about the status of the abstract.
  5. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  6. Submission of the abstract constitutes consent of all authors that CDISC will make presentation(s) and paper(s) available online, whether in video or PDF format, to the conference attendees, and after six (6) months, to the CDISC member community.

WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION!

Questions?

If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at events@cdisc.org.